Stable oil-in-glycerin emulsion

ABSTRACT

The invention provides a composition of matter comprising a stable oil-in-glycerin emulstion containing at least one oil, at least one emulsifier and glycerin.

CROSS REFERENCES TO RELATED APPLICATIONS

This application is a §371 national stage filing of PCT/IL00/00142 filedMar. 9, 2000, and claims the benefit of priority from Israel patentapplication IL 129102, filed Mar. 22, 1999, the full disclosures ofwhich are incorporated herein by reference.

TECHNICAL FIELD

The present invention relates to a stable oil-in-glycerin emulsion.

BACKGROUND ART

Oil-in-water emulsions and water-in-oil emulsions are well-known in theart.

Emulsions are thermodynamically non-stable dispersions systemscontaining two immiscible liquids. A large amount of energy is requiredto rupture an internal phase of a liquid into small droplets producingvery large surface and interfacial free energy. This free energy is thedriving force for reuniting the droplets, a phenomenon leading to phaseseparation and the breakdown of the emulsion. Instability in emulsionsis characterized as coalescence, creaming and finally phase separation.Coalescence is the unification of suspended droplets where largerdroplets are produced from smaller ones. Creaming is the migration ofparticles (usually in an upward direction), due to differences ofspecific weight between internal and external phases. Creaming bringsmany droplets closer together, thereby increasing coalescence.Coalescence, in turn, increases creaming since larger droplets migrateat a quicker rate. Coalescence is irreversible while creaming may bereversible. Phase separation is the final stage of emulsion break.

Stable emulsions coalescence and cream at a very low rate. The low rateallows for an adequate shelf life of an emulsion. Emulsions areconsidered stable if no phase separation is detected for a definedperiod of time and conditions and if creaming occurs, it is practicallyreversible.

Many emulsion classifications are described in the literature. Basicemulsions are classified by the type of liquid constituting the internalor external phases. The classical types are oil-in-water or water-in-oilemulsions. Cosmetic emulsions, for example, are named according to theiruse: cold cream, absorbing creams, night creams, vanishing cream,moisturizing creams, lotions, etc.

Known emulsions are routinely used as a delivery vehicle of activesubstances. However, said vehicle is not optimal for the proper deliveryof all types of active substances.

Known emulsions are not optimal, for example, in the delivery ofessential oils.

Essential oils are potent bioactive herbal extracts which are regularlyutilized in the practice of phytomedicine, aromatherapy and homeopathy.Essential oils are also used as food additives and in spices. Essentialoils are hydrophobic and practically insoluble in water or glycerin.Said oils are, however, soluble in alcohols such as ethyl alcohol andisopropanol and in oils such as tryglycerides and organic solvents suchas acetone. In light of the above, essential oils are regularly andtraditionally dispensed in vegetable tryglyceride oils or alcohol.Dispersion of essential oils in water is possible through theutilization of ample amounts of surfactant solubilizers or emulsifiers,however these solutions tend to be unstable.

The delivery of essential oils within pure oils such as vegetabletryglyceride oils is possible, but is not always optimal. For example,the use of oils within the oral cavity or on the scalp is not pleasantand undesirable due to the oily remnant and the need for removal of saidremnant with soap.

A further drawback of known delivery vehicles is the presence of alcoholtherein.

Recent scientific data suggests that alcohol may play a role in toxicand genotoxic biological effects. Consumers are therefore refrainingfrom using products containing alcohol, especially for sensitive bodyorgans such as for the oral cavity and babies' skin. Alcohol is anirritant to the skin, scalp, mucous membrane and gastrointestine. In theoral cavity alcohol has a foul taste which is especially unpleasant foryoung and elderly people. Alcohol bums tissues in a way that delaystissue healing after skin traumas. Alcohol dehydrates the skin, mucousmembrane and tissues, which dehydration causes discomfort and pain.Therefore medical research is investing in finding alcohol freemedicaments.

DISCLOSURE OF THE INVENTION

In light of the above, the present invention provides a stableoil-in-glycerin emulsion that can perform as an adequate storage anddelivery vehicle for bioactive, water insoluble active ingredients,including essential oils.

According to the present invention there is provided a composition ofmatter comprising a stable oil-in-glycerin emulsion containing at leastone oil, at least one emulsifier and glycerin.

In a preferred embodiment there is provided a composition of matterwherein the emulsion further comprises at least one bioactive component,wherein said bioactive component is selected from the group consistingof a plant extract, an essential oil, and an oleoresin.

The present invention also provides a composition of matter wherein saidemulsion is substantially alcohol free.

In a preferred embodiment of the present invention said oil is selectedfrom the group consisting of at least one mineral oil, at least onevegetable oil, at least one water insoluble botanical extract andmixtures thereof wherein said vegetable oil is a vegetable tryglyceride,wherein said vegetable tryglyceride is a medium chain tryglyceride,wherein said medium chain tryglyceride is a capric-caprylic tryglycerideand wherein said capric-caprylic tryglyceride is fractionated coconutoil.

In a most preferred embodiment said oil is selected from the groupconsisting of a plant extract, an essential oil, and an oleoresin andfunctions also as an active ingredient.

In another preferred embodiment said mineral oil is a paraffin oil.

In preferred embodiments of the present invention the followingquantities are preferable:

a) said vegetable tryglyceride is present in an amount ranging fromabout 1-40 wt/wt %, or from 2-20 wt/wt %;

b) said emulsifier is present in an amount ranging from about 0.1-20wt/wt %, or from about 0.1-5 wt/wt %; and

c) said bioactive component is present in an amount ranging from about0.1-20 wt/wt %.

In a most preferred embodiment said emulsifier biodegradable (i.e.,degradable in the human body and the environment) and/or issubstantially free of polyoxyethylene.

In a most preferred embodiment of the present invention said bioactivecomponent is water insoluble.

In an even further preferred embodiment of the present invention saidglycerin constitutes a continuous phase of said emulsion and a minorportion of water is included in said glycerin phase.

It is important to note that the botanical extract of the presentinvention may have has anti-inflammatory, anti-bacterial,anti-parasitic, anti-viral, immunity modulation and/or stress relaxantproperties.

It also should be noted that the emulsifier of the present invention maybe one of the following:

a) a fatty acid conjugated to a natural hydrophilic molecule;

b) a fatty alcohol conjugated to a natural hydrophilic molecule;

c) an ester of fatty acid/s and carbohydrates or poly-carbohydratesaccharides; and

d) an ether of fatty alcohol/s and carbohydrates or poly-carbohydratesaccharides.

In a preferred aspect of the invention, the combination of anoil-in-glycerin emulsion and a plant extract enables the dispersion of awater insoluble bioactive component in a biocompatible, safe andconvenient dosage form, while avoiding the disadvantages associated withclassical vehicles.

The oil-in-glycerin emulsions are pleasant for use on the skin and onmucous membranes such as the oral cavity, ears and scalp. Additionally,the emulsions of the present invention are well acceptedorganoleptically and physiologically, hence, offering good patientcompliance. The oil-in-glycerin emulsions are easy to apply, as well asbeing easy to remove after the substantial absorption thereof. Stableoil-in-glycerin emulsions containing essential oils are advantageous forobtaining physical and chemical stability of essential oil compositions.

As will be realized, the present invention provides an emulsion which isalcohol free, has a prolonged shelf life and improved heat stability forwithstanding elevated temperatures during a long period of time.Furthermore, the oil-in-emulsion resists sub-zerotemperatures, it isstable upon freezing and does not break at minus 20° C. Thaw ofoil-in-glycerin emulsions is simple and does not affect originalproperties.

While many publications exist in which glycerin, oils and emulsifiersare mentioned as possible components, no publication has been foundteaching or suggesting a stable oil-in-glycerin emulsion of the typedefined and claimed herein.

Thus, e.g., in U.S. Pat. No. 5,980,925 there is described an anchoringagent or dermal anchoring/substantive agent that enhances the activityof active ingredients, such as anti-micorbial agents like chlorhexidinegluconate. Glycerin is mentioned in this patent as an example of such anactive anchoring agent that has the desired bioactivity.

While said patent teaches gels and creams having a glycerin content,there is no referral in said patent to a stable oil-in-glycerin emulsionand there is no referral to solubilizing a poorly water-soluble or waterinsoluble compounds or hydrophobic compounds.

Practically, the glycerin may also be incorporated in a cream for thepurpose of enhancing the activity of anti-microbial compounds, howeverthe patent does not teach or suggest a dispersion system of oil dropletsdispersed and stabilized in glycerin.

Oil-in-glycerin emulsions are easily prepared. It is possible to producecoarse oil-in-glycerin emulsions of 10 to 50 microns droplet size withsimple stirring and without resort to the use of high shear mixers. Itis also easy to control droplet size by the utilization of appropriatemixing equipment and energy input. Fine oil-in-glycerin emulsions,having a mean droplet size of five micron, are achieved with aconventional “Silverson” type mixer at moderate speed and a shortduration of mixing. High speed “Silverson” type mixing is sufficient toobtain emulsions containing 500 to 3000 nanometers (0.5 to 3 microns)droplets. Further reduction of droplet size is possible by applyingappropriate equipment of high pressure and high shear output.

The present invention relates to oil-in-glycerin emulsions in which theoil is the internal phase and the glycerin is the external, continuousphase. The phase inversion ratio varies markedly according to thefollowing variables: emulsifier type, oil nature, temperature and thevarious additives and said variables are chosen to support condition foran oil-in-glycerin emulsion. Thus, the amount of emulsifier oremulsifiers should be adjusted to the internal oil volume ratio and moreemulsifier is needed when a larger ratio of oily phase is present.Properly formulated oil-in-glycerin emulsions may contain up to equalparts of oil and glycerin phases.

The oil-in-glycerin emulsions of the present invention are well suitedfor pharmaceutical, complementary medicine, cosmetic, nutraceutical andveterinary use, as well as for topical external use on skin or mucousmembrane and internal oral consumption.

A botanical essential oil is a volatile mixture of esters, aldehydes,alcohols, ketones and terpenes, which is prepared from botanicalmaterials or plant cell bio-mass from cell culture. Examples ofessential oils include, but are not limited to, oil of cinnamon,prepared from the dried bark of the roots of Cinnamomum zeyloriaceae;cajeput oil, eucalyptus oil, prepared from the fresh leaves and branchesof various species of Eucalyptus, such as E. globulus; fennel oil,prepared from dried ripe fruit of Foeniculum vulgare; geranium oil,prepared from the aerial parts of Pelargonium species; girofle oil,lavander oil, prepared from fresh flowering tops of Lavandula speciessuch as Lavandula officinalis; lemon oil, obtained from the fresh peelof Citrus lemon; spearmint oil, prepared from the aboveground parts offresh flowering Mentha species, such as M. spicata; myrte oil, origanooil, pine oil, rosemary oil, prepared from tops or leafy twigs ofRosmarinus officinalis; sarriette oil, thyme oil, prepared from theleaves and flowering tops of Thymus vulgaris; and tea-tree oil, obtainedfrom the leaves of Melaleuca olternifolia. Hypericum oil, Pinus, Staranise seeds oil and Garlic oil (Allium sativum oil).

Alcohol free herbal extracts are extracts of plant materials, such as atincture of botanical materials, which are prepared by contactingbotanical material with a solvent [British Herbal Pharmacopeia, Peter R.Bradley, ed., British Herbal Medicine Association, 1983; and BritishHerbal Compendium, Peter R. Bradley, ed., British Herbal MedicineAssociation, 1992]. The solvent can be aqueous or organic, or acombination thereof. The most preferred solvents are hydroalcoholicsolvents as defined in British Herbal Pharmacopoeia and Compendium. Theextracts containing alcohol are further processed and alcohol isevaporated and removed by lyophilization, spray drying, simpleevaporation by heat or under vacuum. The dry product mass is furthersolubilized and dissolved in an appropriate, glycerin water mixture. Thebotanical material can include, but is not limited to, one or more ofthe following species: Plantago (Plantago major), Hypericum(Hypericaceae perforatus), Echinacea (also known as Coneflower)(Echinaceae species such as Echinaceae angustifoliae radix andEchinaceae purpurea), Baptisia, Calendula, Myrrh, Phytolaca, Salvia,Catechu black, Krameria, Tsuga, Rosmarinus, Styrax, Crataegus,Glycerrhiza (Glycerrhiza glabra), Angelica, Krameria, Matricaria, Mallowand Sage. Chamomile, Hammamelis, Aloe vera, Nettle (Urtica). Kava Kava,Noni fruit (Morinda citrifolia), Feverfew (Tanacetum parthenolide),Astragulus.

An emulsifier is a surface active agent or protective colloid that iscapable of suspending the oily phase and stabilizing the emulsion bycoating the oil droplets and avoiding the separation of the internaloily phase. The film coat produced by the emulsifier is a barrierbetween the immiscible phase and also prevents droplets association,coagulation and coalescence. Examples of emulsifier include, but are notlimited to, non-ionic surface active agents of polyethyleneglycolderivatives conjugated via ether or ester bond to one or more free fattyacids or sorbitans or fatty acids sorbitan conjugares or carbohydratesor mono or di glycerides or block copolymers with polyoxypropylene, suchas, Tween 80 (polyoxyethylebe sorbitan monooleate) and Tween 20(polyoxyethylene sorbitan monolaurate). Fatty acids conjugated tocarbohydrates or sugars or polysugars, such as cetearyl glucoside orpolyglucosides or sorbitan monooleate (Span 80) or sorbitan monolaurate(Span 20) or polyoxyethylene monostearate (Myrj 45) or polyoxyethylenevegetable oil (Emulphor). Cationic or anionic surfactants, such assodium sulfated alkyls, (sodium lauryl sulfate), triethanol-amineoleate, cetyl piridinium chloride. Amphotheric surfactants, such asproteineted fatty acids, amido-betaine and fatty acids conjugates.Protective colloids such as polysaccharides gums, Xanthan gums,Tragacanth, Gum arabica, Acacia, or proteins or conjugated proteinscapable of forming and protecting stable oil in glycerin emulsion.

Typical oil-in-glycerin emulsions are characterized by having viscosityof 15,000 to 25,000 centipoise and neutonian flow. Viscosity may bereduced by the addition of water. The oil-in-glycerin emulsion viscositymay be controlled by addition of viscosity forming agents, such as,carbomers, carbopol, cellulose derivatives or natural gums, such asXanthan gum or colloidal fumed silica. Semi-solid oil-in-glycerinemulsions are suitable for topical and mucosal application, foreffective local delivery of water insoluble bioactives. Oil-in-glycerinemulsions are advantageous for oral administration to achieve enhancedoral bioavailability for hydrophobic bioactives. Oil-in-glycerinemulsions may be used orally in a viscous fluid state, syrup like form,or within soft gelatin capsules.

An oil-in-glycerin emulsion having a low oil to glycerin ratio (R<10)tends to cream. When creaming takes place at 15° C. It may occur duringa period ranging from days to weeks. At 35° C. the period is shorter,ranging between hours and days. It should be noted that creaming iareversible process. In cases where creaming or reversible separation hasoccurred, re-dispersion is achieved by light shaking. An oil-in-glycerinemulsion having a high ratio (R>10), may not cream even after severalweeks at a temperature of 35 C. The creaming mentioned above is alsoinfluenced by the amount and type of bioactives. For example, hammamelisfluid extract glycerin effects faster creaming in comparison to aloevera or echinacea fluid extract glycerin. Some essential oils influencethe stability of an emulsion, while others do not.

Oil-in-glycerin emulsions are easily and readily diluted with water. Theglycerin is dissolved in the water and the oily phase stays emulsifiedfor as long as twenty four hours, resulting in stableoil-in-water/glycerin emulsion which is ready to use.

Oil-in-glycerin emulsions are suitable for use in humans and animals, onskin, scalp, mucous membrane, ear instillation, oral rinse, and for oralconsumption. The emulsions the present invention are applicable to thenose and eyes only after dilution with water, since glycerin is notphysiologically acceptable at high concentrations.

The oil-in-glycerin emulsions are basically neutonian and flow easilyout of any commercial consumer product orifice opening or dropper.Oil-in-glycerin emulsions may be packaged in glass, aluminum or plasticcontainers.

Viscosity is easily controlled by the addition of viscosity agents toproduce gels for use as rectal or vaginal inserts. Oil-in-glycerinemulsion are readily incorporated into semi-solid creams.Oil-in-glycerin emulsions may be encapsulated in soft gelatin capsules.Oil-in-glycerin emulsions may be used as syrups for oral consumption.

Oil-in-glycerin emulsions may contain high surfactant levels to promotefoam and cleaning effects in shampoos and mouthwashes.

The oily phase is preferably liquid lipids but may also contain solidlipids alone or in combination with liquid lipids. The amount ofrequired emulsifier to stabilize the emulsion depends on the amount andtype of oily phase and emulsifier. Generally, 0.5% to 2% are adequate tostabilize oil-in-glycerin emulsions. The more suitable surfactants foroil-in-glycerin emulsions have a hydrophilic moiety of carbohydrate orpolyethylene type, such as sugar, polysugar, polyethyleneoxide orpolyglycerols and derivatives or combinations thereof such as sorbitanpolyethylene oxides. The hydrophobic moiety of the surfactants mentionedabove is preferably a fatty acid or alcohol having a 10-18 carbon chain.

Phospholipids may be added to oil-in-glycerin emulsions, however,phospholipids alone are not sufficient emulsifiers to stabilize manyoil-in-glycerin emulsions.

While the invention will now be described in connection with certainpreferred embodiments in the following examples so that aspects thereofmay be more fully understood and appreciated, it is not intended tolimit the invention to these particular embodiments. On the contrary, itis intended to cover all alternatives, modifications and equivalents asmay be included within the scope of the invention as defined by theappended claims. Thus, the following examples which include preferredembodiments will serve to illustrate the practice of this invention, itbeing understood that the particulars shown are by way of example andfor purposes of illustrative discussion of preferred embodiments of thepresent invention only and are presented in the cause of providing whatis believed to be the most useful and readily understood description offormulation procedures as well as of the principles and conceptualaspects of the invention.

EXAMPLES

The oily and glycerin phases are heated separately to 70° C. until allingredients melt and are well dissolved. The phases are combined whilemixing. Mixing may be performed with any mixer, blender, homogenizer,etc. which is used for producing emulsions. Oil-in-glycerin emulsionsmay also be prepared by heating all the ingredients, including oil,glycerin and emulsifiers, except for heat sensitive bioactives, in asingle batch, mixing to achieve melting of solids and with continuedmixing until cooled to room temperature, with the addition of any heatsensitive bioactives to the cooling mixture.

The oil-in-glycerin emulsions presented herein in the following examplesare stable for an adequate period of time. The following examples are todemonstrate various compositions that do not undergo phase separation orbreakdown for at least one year at room temperature and for many days orweeks at 35° C. Oil-in-glycerin emulsions that cream within this timeare easily redispersed while maintaining original properties.Redispersion of the present oil-in-glycerin emulsions is easilyperformed by gentle shaking of the sample for a short period of time.

DESCRIPTION OF PREFERRED EMBODIMENTS Example 1 Oil-in-glycerin LiquidEmulsion; Plain Base

Ingredient % W/W Glycerin 84.0 Medium chain trygliceride (MCT) oil 15.0Cetearyl-glucoside 1.0

Example 2 Oil-in-glycerin Emulsion; Plain Natural Base

Ingredient % W/W Glycerin 81.6 Medium chain trygliceride (MCT) oil 15.0Cetearyl-oil 1.0 Mono-di-glycerides 1.0 Oleic acid 0.2 Beeswax 1.0Xanthan gum 0.2

Example 3 Oil-in-glycerin Emulsion; Cleansing and Foaming Base

Ingredient % W/W Glycerin 80.5 MCT oil 11.0 Jojoba oil 4.0Decyl-glucoside 2.0 Cocamidopropylbetaine 2.0 Vitamin E acetate 0.5

Example 4 Oil-in-glycerin Emulsion Liquid Base with Preservatives

Ingredient % W/W Glycerin 83.3 MCT oil 15.0 Cetearyl-glucoside 1.0Vitamin E acetate 0.5 Propyl paraben 0.1 Methyl paraben 0.1

Example 5 Ear Drops

Ingredient % W/W Glycerin 84.3 MCT oil 12.0 Cetearyl-glucoside 1.0Vitamin E acetate 0.5 Eucalyptus oil 1.0 Thyme oil 0.5 Hpericum oil 0.5Chamomile dry extract 0.2

Example 6 Ear Drops

Ingredient % W/W Glycerin 83.3 MCT oil 12.0 Tween 80 2.0 Vitamin Eacetate 0.5 Eucalyptus oil 1.0 Thyme oil 0.5 Hpericum oil 0.5 Chamomiledry extract 0.2

Example 7 Ear Drops

Ingredient % W/W Glycerin 80.3 MCT oil 12.0 Echinacea fluid extractglycerin 2.0 Aloe vera fluid extract glycerin 2.0 Cetearyl-glucoside 1.0Vitamin E acetate 0.5 Eucalyptus oil 1.0 Thyme oil 0.5 Hpericum oil 0.5Chamomile dry extract 0.2

Ear drops vehicles should be non-alcoholic and preferably without watersince water enhances bacterial proliferation. Too much water in the earsmay lead to swimmer's ear syndrome. Examples 5 to 7 are therefore mostpreferred ear drops vehicles, enabling good delivery of hydrophobicbioactives as well as hydrophilic bioactives to the ear without water oralcohol.

Example 8 Anti-lice: Hair, Scalp and Body Treatment

Ingredient % W/W Glycerin 78.5 MCT oil 10.0 Cetearyl-glucoside 1.5Beeswax 0.5 Vitamin E acetate 0.5 Star anise oil 3.0 Eucalyptus oil 3.0Rosemarine oil 3.0

Essential oils are used traditionally to expel lice by killing the liceand preventing recurrent contamination. The anti-lice oil-in-glycerinemulsion containing essential oils is non-greasy, easy to clean andalcohol free.

Example 9 Oral Rinse, Anti Plaque Concentrated Wash for Dilution

Ingredient % W/W Glycerin 80.3 MCT oil 12.0 Tween 80 2.0 Vitamin Eacetate 0.5 Eucalyptus oil 3.0 Thyme oil 1.0 Cinnamon oil 1.0 Chamomiledry extract 0.2 Sodium fluoride 1.5 Chlorohexidine digluconate 0.05

The concentrated viscous liquid according to the present invention asset forth in this example is intended for dilution five to ten timeswith tap water by the user before use. The dilution and mixing withwater is instantaneous requiring only a few seconds of gentle swirlingof the glass. The diluted solution is pleasant for a mouthwash or breathrefresher and may be formulated with or without fluoride and in variousflavors to suit various populations' preferences.

Example 10 Oral Rinse, Anti Fungal & Aphtous, Concentrated Wash forDilution

Ingredient % W/W Glycerin 81.3 MCT oil 12.0 Cetearyl-glucoside 1.5Vitamin E acetate 0.5 Eucalyptus oil 0.5 Thyme oil 0.5 Cinnamon oil 0.5Tea-tree oil 0.5 Hypericum oil 0.5 Chamomile dry extract 0.2 Echinaceafluid extract glycerin 2.0

Essential oils are potent anti-bacterials used traditionally for oralhygiene and treating gums diseases. The oil-in-glycerin emulsionmouthwashes of examples 9 and 10 are typical examples foroil-in-glycerin emulsions which must be diluted prior to use.

Example 11 Oral Toothpaste

Ingredient % W/W Glycerin 61.8 Fumed silica 20.0 MCT Oil 12.0 Tween 802.0 Sodium lauryl sulphate 1.0 Vitamin E acetate 0.5 Eucalyptus oil 1.0Thyme oil 1.0 Cinnamon oil 0.5 Chamomile dry extract 0.2 Sodium fluoride0.15

Addition of solid powder may convert viscous liquid oil-in-glycerinemulsions into semi-solid paste such as toothpaste. It is possible toobtain regular as well as transparent or gel toothpaste.

Example 12 Topical Skin Application, Mosquitoes Repellent

Ingredient % W/W Glycerin 76.8 MCT oil 12.0 Cetearyl-glucoside 4.0Cetearyl octanoate 4.0 Xanthan gum 1.5 Vitamin E acetate 0.5 Eucalyptusoil 0.5 Thyme oil 0.5 Geranium oil 0.5 Hpericum oil 0.5 Rosmarinus oil0.5 Aloe vera dry extract 0.2

Example 13 Topical Skin Application, Anti-acne

Ingredient % W/W Glycerin 76.8 MCT oil 12.0 Cetearyl-glucoside 4.0Cetearyl octanoate 4.0 Xanthan gum 1.5 Vitamin E acetate 0.5 Eucalyptusoil 0.5 Thyme oil 0.5 Geranium oil 0.5 Rosmarinus oil 0.5 Aloe vera dryextract 0.2 Hypericum dry extract 0.2

Example 14 Topical Skin Application, Anti-wart (Veruca)

Ingredient % W/W Glycerin 74.8 MCT oil 10.0 Cetearyl-glucoside 4.0Cetearyl octanoate 4.0 Xanthan gum 1.5 Garlic oil 1.0 Citronella oil 1.0Hpericum oil 1.0 Vltamin E acetate 0.5 Sanguinaria dry extract 0.5 Thujaoccidentalis dry extract 0.5 Aloe vera dry extract 0.2

Example 15 Topical Skin Application, Anti-fungal

Ingredient % W/W Glycerin 71.3 MCT oil 10.0 Beeswax 6.0Cetearyl-glucoside 5.0 Phytolaca fluid 2.0 extract glycerin Echinaceafluid 2.0 extract glycerin Xanthan gum 1.5 Vitamin E acetate 0.5Geranium oil 0.5 Hpericum oil 0.5 Tea-tree oil 0.5 Aloe vera dry extract0.2

Examples 11 to 15 are presented to demonstrate semi-solid cream typeoil-in-glycerin emulsions.

Example 16 Topical Skin Application, Muscles and Joints Pain Relief

Ingredient % W/W Glycerin 71.3 MCT oil 10.0 Beeswax 6.0Cetearyl-glucoside 5.0 Xanthan gum 1.5 Vitamin E acetate 0.5 Rosmarinusoil 1.0 Lavendula (thyme)oil 1.0 Harpagophytum dry extract 1 Hmmamelisdry extract 1 Arnica dry extract 1

Example 17 Lip Balsam, For Cracked Lips

Ingredient % W/W Glycerin 68.3 MCT Oil 10.0 Cetearyl alcohol 6.0 Beeswax6.0 Cetearyl-glucoside 5.0 Xanthan gum 1.5 Vitamin E acetate 0.5Eucalyptus oil 0.5 Thyme oil 0.5 Geranium oil 0.5 Hpericum oil 0.5Rosmarinus oil 0.5 Aloe vera dry extract 0.2

Example 18 Mucosal Application, Concentrated Vaginal Hygiene

Ingredient % W/W Glycerin 81.0 MCT oil 12.0 Cetearyl-glucoside 1.0 Tween80 2.0 Vitamin E acetate 0.5 Eucalyptus oil 1.0 Thyme oil 0.5 Hpericumoil 0.5 Geranium oil 0.5 Chamomile dry extract 0.5 Aloe vera dry extract0.5

This is a concentrated product which may be diluted by the user three tofive times with water before use.

Example 19 Mucosal Application, Anti-hemorrhoid

Ingredient % W/W Glycerin 80.0 MCT oil 7.0 Cetearyl-glucoside 4.0Cetearyl-octanoate 4.0 Vitamin E acetate 0.5 Thyme oil 0.5 Hpericum oil0.5 Geranium oil 0.5 Tea-tree oil 0.5 Propolis 0.5 Hammamelis dryextract 0.5 Echinacea dry extract 0.5 Calendula dry extract 0.5 Comfreydry extract 0.5

Example 20 Alcohol Free Vehicle for Oral Use of Poor Water SolubleBioactives

Ingredient % W/W Glycerin 80.5 MCT oil 15.0 Cetearyl-glucoside 1.0Lecithin 1.5 Vitamin E acetate 0.5 Dry powder bioactive 1.0

Example 21 Alcohol Free Vehicle for Oral Use of Poor Water SolubleBioactives

Ingredient % W/W Glycerin 80.5 MCT oil 12.0 Cetearyl-glucoside 1.0 Tween80 1.0 Vitamin E acetate 0.5 Liquid or liquid 5.0 extract bioactive

Example 22 Oral Oil-in-glycerin in Soft Gelatin Capsules

Ingredient % W/W Glycerin 64.5 MCT oil 30.0 Cetearyl-glucoside 2.0Mono-di-glycerides 2.0 Vitamin E acetate 0.5 Leucopens 0.5 Carotenoids0.5

Example 23 Oral Syrup Like, Liquid Oil-in-glycerin emulsion

Ingredient % W/W Glycerin 80.5 MCT oil 15.0 Sugar esters (E473) 2.0Vitamin E acetate 0.5 Artemisia dry extract 1.0 Garlic dry extract 1.0

It will be evident to those skilled in the art that the invention is notlimited to the details of the foregoing illustrative examples and thatthe present invention may be embodied in other specific forms withoutdeparting from the essential attributes thereof, and it is thereforedesired that the present embodiments and examples be considered in allrespects as illustrative and not restrictive, reference being made tothe appended claims, rather than to the foregoing description, and allchanges which come within the meaning and range of equivalency of theclaims are therefore intended to be embraced therein.

What is claimed is:
 1. A topically applicable stable oil-in-glycerincomposition comprising a continuous glycerin phase, at least onevegetable oil, at least one biodegradable emulsifier and at least onebioactive essential oil component for topical, external use on skin andmucosal surfaces wherein the bioactivity of said essential oil isselected from the group consisting of topical anti-inflammatoryactivity, topical anti-fungal activity, topical anti-bacterial activity,topical anti-parasitic activity, and topical anti-viral activity, andwherein said essential oil is a volatile mixture of esters, aldehydes,alcohols, ketones, and terpenes.
 2. A topically applicable stableoil-in-glycerin composition according to claim 1, wherein saidemulsifier of vegetable origin is made by condensation of at least onevegetable fatty acid and a vegetable saccharide or disaccharide orpoly-saccharide.
 3. A topically applicable stable oil-in-glycerinemulsion composition according to claim 1, wherein said emulsion issubstantially alcohol free.
 4. A topically applicable stableoil-in-glycerin emulsion composition according to claim 1, wherein saidglycerin constitutes a continuous phase of said emulsion and a minorportion of water is included in said glycerin phase.
 5. A topicallyapplicable stable oil-in-glycerin emulsion composition according toclaim 1, wherein said vegetable oil is jojoba oil.
 6. A topicallyapplicable stable oil-in-glycerin emulsion composition according toclaim 1, wherein said vegetable oil is a vegetable tryglyceride.
 7. Atopically applicable stable oil-in-glycerin emulsion compositionaccording to claim 6, wherein said vegetable tryglyceride is a mediumchain tryglyceride.
 8. A topically applicable stable oil-in-glycerinemulsion composition according to claim 7, wherein said medium chaintryglyceride is a capric-caprylic tryglyceride.
 9. A topicallyapplicable stable oil-in-glycerin emulsion composition according toclaim 8, wherein said capric-caprylic tryglyceride is fractionatedcoconut oil.
 10. A topically applicable stable oil-in-glycerin emulsioncomposition according to claim 1, wherein said oil is present in anamount ranging from about 0.1-40 wt/wt %.
 11. A topically applicablestable oil-in-glycerin emulsion composition according to claim 1,wherein said oil is present in an amount ranging from about 2-20 wt/wt%.
 12. A topically applicable stable oil-in-glycerin emulsioncomposition according to claim 1, wherein said emulsifier is present inan amount ranging from about 0.1-20 wt/wt %.
 13. A topically applicablestable oil-in-glycerin emulsion composition according to claim 1,wherein said emulsifier is present in an amount ranging from about 0.1-5wt/wt %.
 14. A topically applicable stable oil-in-glycerin emulsioncomposition according to claim 2, wherein said bioactive essential oilcomponent is present in an amount ranging from about 0.1-20 wt/wt %. 15.A topically applicable stable oil-in-glycerin emulsion compositionaccording to claim 1, wherein said emulsifier is substantially free ofpolyoxyethylene.
 16. A topically applicable stable oil-in-glycerinemulsion composition according to claim 1, wherein said bioactiveessential oil component has low water solubility.
 17. A topicallyapplicable stable oil-in-glycerin emulsion composition according toclaim 1, for use in oral care.
 18. A topically applicable stableoil-in-glycerin emulsion composition according to claim 1, for use invaginal hygiene.
 19. A topically applicable stable oil-in-glycerinemulsion composition according to claim 1, for veterinary use.
 20. Atopically applicable stable oil-in-glycerin composition comprising acontinuous glycerin phase, at least one vegetable oil, at least onebiodegradable emulsifier of vegetable origin made by condensation of atleast one fatty acid with a vegetable carbohydrate or polycarbohydrateand at least one bioactive essential oil component for topical, externaluse on skin and mucosal surfaces wherein the bioactivity of saidessential oil is selected from the group consisting of topicalanti-inflammatory activity, topical anti-fungal activity, topicalanti-bacterial activity, topical anti-parasitic activity, and topicalanti-viral activity, and wherein said essential oil is a volatilemixture of esters, aldehydes, alcohols, ketones, and terpenes.